Senior Quality Engineer - Galway - 102417
Our client, a medical device company in Galway is currently looking to recruit a Senior Quality Engineer
for their site.
The Senior Quality Engineer provides a support role to the Quality Manager in the routine maintenance of the companys International’s Quality Management Systems and in Quality related projects. The Senior Quality Engineer reports to the QA & RA Manager
Responsibilities and Duties
- Possesses and applies comprehensive knowledge of Quality, and its application withinthe companys, to the completion of complex assignments.
- Advanced knowledge of the companys organization’s operations and practices to enable informed decisions, and providing direction to Quality team and other functional areas.
- Responsibility for delivery of projects originated in QA or participate within Core Team for Quality deliverables of business wide projects.
- Identifies key barriers/core problems and applies problem-solving skills in order to deal creatively with complex situations. Troubleshoots and resolves complex problems with effective solutions.
- Makes decisions under conditions of uncertainty, sometimes with incomplete information, that produce effective end results. Applies risk assessment techniques in such circumstances.
- Independently performs assignments with instruction limited to results expected. Determines and develops approach to solutions.
- Drives business improvements through mentoring and support for the continuous improvement initiatives.
- Escalation point for quality related non-conformances and CAPAs.
- Drives compliance cross functionally in alignment with the regional objective for collaboration and multi-site ISO13485 certification.
- Excellent interpersonal, written and verbal communication skills, including ability to make clear, well founded decisions regarding conformity during audits.
- Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
- Proficient with MS Word, Excel, Power Point, and management of spreadsheets.
Education & Experience
- Third level qualification.
- Minimum 5 years of experience in medical device industry with minimum 3 year of progressively responsible positions, including;
- competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP),
- awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL)
- Broad knowledge of engineering and technical applications applied in development of medical devices useful.
Job Characteristic Profile
• Understands the business strategic direction and is able to pro-actively conceive and develop a training plan which is aligned.
• Pro-actively identifies potential future skill gaps and plans accordingly.
• Is familiar with broad suite of the companys and 3rd party products.
• Understands the different dynamics with each team and adopts his/her approach accordingly.
• Partners where necessary with peer groups within and outside the company.
• Is comfortable and confident in interfacing with senior management.
• Can positively influence employees at all levels on the need for continuous skill enhancement.
• Can interface professionally with external auditors.
• Can develop plans and policies to meet continually changing business needs.
• Identifies best practice training organisations and implements learning in the company
• Continually seeks to improve the effectiveness of training across the business.
• Implements his/her plan with 100% attention to detail and success.
• Associates directly with all customer related metrics across the site and builds connectivity of training plans in support of same.
For further information on this Senior Quality Engineer role in Galway please contact Bimi Felix on 086 8395533 / firstname.lastname@example.org
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